PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV (pharmacovigilance) issues.
Due to the relaunch of the EMA website in December 2023, you will find the current links to the entries prior to December 01, 2023 at https://www.ema.europa.eu
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Phenylpropanolamine New
PSUR-outcome
|
07/03/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Spironolactone New
PSUR-outcome
|
06/03/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Fluticasone furoate New
PSUR-outcome
|
25/02/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Tacrolimus (systemic formulations) New
PSUR-outcome
|
24/02/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Estradiol New
Additional template
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24/02/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Estradiol / Nomegestrol acetate New
PSUR-outcome
|
18/02/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
Oxaliplatin New
PSUR-outcome
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06/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nebivolol New
PSUR-outcome
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04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Promethazine New
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ambrosia Artemisiifolia (sublingual use) New
PSUR-outcome
|
04/02/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
